Clinical Policy: Armodafinil (Nuvigil) Reference Number: PA.CP.PMN.35 Effective Date: 01/18 Coding Implications Last Review Date: 04/19 Revision Log
Description Armodafinil (Nuvigil®) is a wakefulness-promoting agent.
FDA approved indication Nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with: • Obstructive sleep apnea (OSA) • Narcolepsy • Shift work disorder (SWD)
Limitation(s) of Use: In OSA, Nuvigil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Nuvigil for excessive sleepiness.
Policy/Criteria Provider must submit documentation (including office chart notes and lab results) supporting that member has met all approval criteria
It is the policy of Pennsylvania Health and Wellness® that Nuvigil is medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Narcolepsy (must meet all): 1. Diagnosis of narcolepsy; 2. Age ≥ 17 years; 3. Failure of a 1 month trial of one of the following central nervous system (CNS) stimulants at up to maximally indicated doses within the last 6 months, unless contraindicated or clinically significant adverse effects are experienced: amphetamine immediate-release (IR), amphetamine; dextroamphetamine IR, dextroamphetamine, or methylphenidate IR; *Prior authorization may be required for CNS stimulants 4. Dose does not exceed 250 mg/day. Approval duration: 12 months
B. Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) (must meet all): 1. Diagnosis of obstructive sleep apnea; 2. Age ≥ 17 years; 3. Documented evidence of residual sleepiness despite compliant CPAP use as monotherapy; 4. Dose does not exceed 250 mg/day. Approval duration: 12 months
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C. Shift Work Disorder (SWD) (must meet all): 1. Diagnosis of shift work disorder; 2. Age ≥ 17 years; 3. Dose does not exceed 150 mg/day. Approval duration: 6 months
D. Fatigue Associated with Multiple Sclerosis (MS) (must meet all): 1. Diagnosis of MS-associated fatigue; 2. Age ≥ 17 years; 3. Failure of 200 mg/day of amantadine and ≥ 10 mg/day of methylphenidate, unless contraindicated or clinically significant adverse effects are experienced; 4. Dose does not exceed 250 mg/day. Approval duration: 12 months
E. Other diagnoses/indications 1. Refer to PA.CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized).
II. Continued Therapy A. All Indications (must meet all): 1. Currently receiving medication via Pennsylvania Health and Wellness benefit or member has previously met initial approval criteria or the Continuity of Care Policy, PA.LTSS.PHAR.01, applies; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed (a or b): a. Narcolepsy, OSA, and MS-associated fatigue: 250 mg per day; b. SWD: 150 mg per day. Approval duration: 12 months
B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Pennsylvania Health and Wellness benefit and documentation supports positive response to therapy or the Continuity of Care Policy, PA.LTSS.PHAR.01, applies; or 2. Refer to PA.CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). Approval duration: 12 months
III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – PA.CP.PMN.53 or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CNS: central nervous system CPAP: continuous positive airway pressure
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FDA: Food and Drug Administration MS: multiple sclerosis OSA: obstructive sleep apnea OSAHS: obstructive sleep apnea/hypopnea syndrome SWD: shift work disorder IR: immediate-release
Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Evekeo® Narcolepsy 60 mg/day (amphetamine) 5 to 60 mg/day PO in divided doses amphetamine/ dextroamphetamine (Adderall®) dextroamphetamine ER (Dexedrine® Spansule®) dextroamphetamine IR (Zenzedi®, Procentra®) methylphenidate IR Narcolepsy 60 mg/day (Ritalin®, 10 to 60 mg/day PO in 2 to 3 divided Methylin®) doses
MS-associated fatigue† Usual effective dose: 10-20 mg PO QAM and noon amantadine MS-associated fatigue† 200 mg/day (Symmetrel®) 200 mg PO once daily or 100 mg PO twice daily Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. †Off-label indication
V. Dosage and Administration
Indication Dosing Regimen Maximum Dose Narcolepsy 150 mg to 250 mg orally 250 mg/day Obstructive sleep apnea once a day Shift work disorder 150 mg orally 150 mg/day once a day as a single dose approximately 1 hour
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prior to the start of work shift MS-associated fatigue† 150 mg every morning 250 mg/day †Off-label indication
VI. Product Availability Tablets: 50 mg, 150 mg, 200 mg, and 250 mg
VII. References 1. Nuvigil Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.; November 2018. Available at: https://nuvigil.com/. Accessed February 26, 2019. 2. Morgenthaler TI, Kapur VK, Brown T, et al. Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin An American Academy of Sleep Medicine Report: An American Academy of Sleep Medicine Report. Sleep. 2007;30(12):1705-1711. 3. Epstein LJ, Kristo D, Strollo PJ Jr, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76. 4. Morgenthaler TI, Lee-Chiong T, Alessi C, et al. Practice Parameters for the Clinical Evaluation and Treatment of Circadian Rhythm Sleep Disorders: An American Academy of Sleep Medicine Report. Sleep. 2007;30(11):1445-1459. 5. Billiard M, Dauvilliers Y, Dolenc-Groselj L, Lammers GJ, Mayer G, Sonka K. Management of narcolepsy in adults. In: Gilhus NE, Barnes MP, Brainin M, editor(s). European handbook of neurological management. 2nd ed. Vol. 1. Oxford (UK): Wiley- Blackwell; 2011. p. 513-28. [118 references] 6. Management of MS-Related Fatigue. Expert Opinion Paper. National Multiple Sclerosis Society; 2006. http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures /Opinion-Paper-Management-of-MS-Related-Fatigue.pdf. 7. Braley TJ; Chervin RD. Fatigue in multiple sclerosis: mechanisms, evaluation, and treatment. SLEEP 2010;33(8):1061-1067. 8. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2019. Available at: http://www.clinicalpharmacology-ip.com/.
Reviews, Revisions, and Approvals Date P&T Approval Date 2Q 2018 annual review: removed requirement pertaining to 1.20.18 hypersensitivity to armodafinil/modafinil; modified initial approval duration from 6 months to 12 months; references reviewed and updated.
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Reviews, Revisions, and Approvals Date P&T Approval Date 2Q 2019 annual review: removed timeframe of trial within the 4.17.19 last 6 for months for stimulants; references reviewed and updated.
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